{
  "abstract": "Introduction Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO 2 90%–96%) compared with usual care.Methods and analysis The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO 2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO2<88%) and hyperoxaemia (SpO2 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.Ethics and dissemination The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.Trial registration number NCT06374225.",
  "authors": [
    {
      "affiliations": [
        "Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "David J Douin"
    },
    {
      "affiliations": [
        "Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA"
      ],
      "name": "John D Rice"
    },
    {
      "affiliations": [
        "Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA"
      ],
      "name": "Mengli Xiao"
    },
    {
      "affiliations": [
        "Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA"
      ],
      "name": "Laurel Beaty"
    },
    {
      "affiliations": [
        "Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA"
      ],
      "name": "Claire Guo"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Cori Withers"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Amy Sullivan"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Erin L Anderson"
    },
    {
      "affiliations": [
        "Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA"
      ],
      "name": "Alex C Cheng"
    },
    {
      "affiliations": [
        "Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA"
      ],
      "name": "Mary K Banasiewicz"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA",
        "Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA"
      ],
      "name": "Matthew W Semler"
    },
    {
      "affiliations": [
        "Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA",
        "Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA"
      ],
      "name": "Bradley Daniel Lloyd"
    },
    {
      "affiliations": [
        "Division of Acute Care Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA"
      ],
      "name": "Amelia Maiga"
    },
    {
      "affiliations": [
        "Section of Pulmonary, Critical Care, Allergy, and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Kevin W Gibbs"
    },
    {
      "affiliations": [
        "Department of Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Gregory R Stettler"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA"
      ],
      "name": "Akram Khan"
    },
    {
      "affiliations": [
        "Department of Surgery, Oregon Health & Science University School of Medicine, Portland, Oregon, USA"
      ],
      "name": "Mitchell B Sally"
    },
    {
      "affiliations": [
        "Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Franklin L Wright"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Neil Aggarwal"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA",
        "Center for COMBAT Research, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Vikhyat S Bebarta"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA",
        "Center for COMBAT Research, University of Colorado School of Medicine, Aurora, Colorado, USA"
      ],
      "name": "Adit A Ginde"
    },
    {
      "affiliations": [],
      "name": "On behalf of the SAVE-O2 AI Investigators"
    }
  ],
  "title": "Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol",
  "uid": "4f991e0f-e644-58e5-b72f-4b0039059766"
}